Stryker wins HDE approval for aneurysm-treating stent system

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Some aneurysms require no treatment, while others are treated with drugs or surgery to prevent their rupture.

The FDA approved Stryker’s stent system that, along with neurovascular embolic coils, treats multiple types of aneurysm. The nod comes under a humanitarian device exemption (HDE).

The Neuroform Atlas device is a small nitinol stent used in conjunction with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms. Aneurysms occur when part of an artery wall weakens and widens or balloons out.

"The hybrid cell stent design of Neuroform Atlas is designed to improve wall apposition, ease of use, deployment accuracy, and catheter re-entry in even the most challenging cases," said Osama Zaidat, M.D., a co-principal investigator and director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio. "The Atlas design may improve patient care by facilitating the treatment of wide neck aneurysms in tortuous and more complex anatomies."

Aneurysms often present no symptoms and can develop over several years, according to the American Heart Association. But a ruptured aneurysm can cause various symptoms—including pain, shock and low blood pressure—and constitutes a medical emergency.

Some aneurysms do not require treatment, while others may be treated with drugs that reduce pressure on the blood vessel and lower the risk of the aneurysm rupturing. Others still may require stenting, but this is not an option for aneurysms in some parts of the body.

"Atlas opens up treatment options for a new segment of patients that would otherwise have been considered too risky to treat,” said Brian Jankowitz, M.D., a co-principal investigator of the investigational trial and director of the NeuroEndovascular Fellowship program at the University of Pittsburgh Medical Center.

The stent system was already available in a number of countries, and Stryker plans to roll the device out in the U.S. immediately.